Idarucizumab (Praxbind) is an intravenous humanized monoclonal antibody fragment that binds to dabigatran (Pradaxa) and its active acyl-glucuronide metabolites to neutralize the direct thrombin inhibitor anticoagulant effects.1,2 Idarucizumab is labeled for immediate reversal of dabigatran's anticoagulant effect for an urgent surgical procedure or for life-threatening bleeding.2

SAFETY

Patients requiring idarucizumab will likely be critically ill adults with comorbid conditions and have a high risk of mortality at baseline. The RE-VERSE AD study, a case series of 90 patients, demonstrated a low risk of adverse thrombotic effects within 72 hours of administration. However, there continued to be significant mortality (20% overall) for patients taking dabigatran, even with the administration of idarucizumab for life-threatening bleeding or emergency surgery.1 It is unknown if idarucizumab reduced or increased mortality compared with supportive care. Because this product contains sorbitol, it can theoretically cause significant reactions, including death, in patients with hereditary fructose intolerance. Safety has not been established in pregnant or lactating women.

TOLERABILITY

Rare adverse effects including dizziness, headache, and nasopharyngitis have been reported with the use of idarucizumab.3,4 However, most patients studied were critically ill and may not have been able to report adverse effects.1 Given the limited duration of use, tolerability issues beyond the appearance of adverse effects already mentioned should not be an issue.